Recall Z-0072-2013— MOOG Medical Devices Group

Name: FDA recall Z-0072-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-26

Class II · Terminated

Class II FDA medical device recall by MOOG Medical Devices Group, initiated 2012-09-26, terminated 2013-04-05. It names one FDA 510(k) clearance: K981816. Product: ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.. Reason: This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by.

Recalling firm: MOOG Medical Devices Group
Classification: Class II
Status: Terminated
Initiated: 2012-09-26
Terminated: 2013-04-05
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K981816 — CUE AMBULATORY VOLUMETRIC INFUSION PUMPBecton Dickinson Curlin, LLC·cleared 1998-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

Reason for recall

This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by

Data sourced from openFDA. This site is unofficial and independent of the FDA.